Wednesday, 30 April 2014

Pfizer isolated in campaign against Indian patent regime, say Indian pharma alliance

A grouping of top domestic drugmakers, Indian Pharma Alliance, has told the government that global pharma giant 'Pfizer Inc is getting isolated in its campaign' to push the US to 'downgrade India' to a 'priority foreign country' in a review of its intellectual property (IP) regime.

The label is the lowest classification any country can find itself in on a US made rating scale for intellectual property protection. At worst, it can trigger trade sanctions against India by the American government.

In one of their sharpest attacks on the company yet, Indian drugmakers allege in a letter to various government arms that Pfizer's insistence to downgrade India could stem from its failure to strike successful tie-ups with generic drug companies in India unlike most of its peers, its dried pipeline of new drugs, and its perceived philosophy that the US IP model is the only right one.

All major global pharma companies have either formed strategic alliances with leading domestic firms for R&D, co-marketing, joint ventures or have acquired them, the letter reviewed by ET said.

"Pfizer signed up with three domestic companies (Hyderabad based Aurobindo Pharma, Bengaluru headquartered Biocon and Ahmedabad centred Claris Pharma) but failed in all of them. It probably feels left out. Pfizer doesn't want others to succeed, where it is left out," it alleges on the $51-billion company's motive to push ahead for India's downgrade.

A Pfizer spokesperson said that strategic partnerships are key in the company's efforts to deliver medicines across globe and it is open to collaborating in India as across the world.

It further says that Pfizer's pipeline of new products has dried up. "By any means, it wants to keep the old patents alive. It has thus chosen a path of litigations as against innovations to maintain its leadership position."

Philosophically, it perceives the US intellectual property rights model to be the only right model for countries of all types irrespective of their stage of economic development, the Indian industry body reckons.

A Pfizer spokesperson disputed these assertions saying "Our pipeline comprises of over 80 innovative therapies including potentially first-in-class vaccines for two deadly hospital-acquired infections, new antibodies for lupus and high cholesterol and the next-generation of targeted therapies for cancer." It is critical that India look holistically at the challenges of public health and prevention and not sacrifice the investment of innovators, she added.

Citing the instance of large US firms like GE, Honeywell Inc, Boeing, the letter by Indian drugmakers claims that not only a large number of American corporations have opposed downgrade of India, even many pharma firms have adopted a more 'conciliatory position'.


India: Delhi High Court’s Decision On Teva Pharmaceutical’s Plaint Against Natco

The Delhi High Court in its recent judgment1 has returned Teva Pharmaceutical's (the Plaintiffs) plea against NATCO (the Defendant) seeking permanent injunction for restraining NATCO from manufacturing Glatiramer Acetate product (Copaxone) for sale in the US. The main reason for the return of plaint as stated in the decision is that the pleadings relating to the product copaxone being sold in Delhi or elsewhere, or the possibility of copaxone being launched in Delhi or elsewhere do not fall into the ambit of the jurisdiction of Delhi High Court. Copaxone (Glatiramer Acetate or Copolymer 1) is used in the treatment of multiple sclerosis.

TEVA'S TUSSLE OVER NATCO and MYLAN COLLABORATION AND THE 2012 SUIT

In an article published in 'Business Line' on 17th January, 2012 it was reported that NATCO collaborated with US based Mylan Pharmaceuticals Inc. ('Mylan') to launch glatiramer acetate in India for the treatment of multiple sclerosis2 . The Plaintiffs further cited the annual report (2010-2011) published by NATCO, and reinstated that NATCO and Mylan signed an agreement relating to the development and marketing of glatiramer acetate in the US which thereby amounts to clear infringement of the Indian Patent.No.190759 and hence sought permanent injunction restraining NATCO from manufacturing Glatiramer Acetate product in India for sale in the US vide CS (OS) No. 3193 of 2012.

As seen here.

Sabinsa, Sami Labs Acquire Two Patents in India

JAMMU, India—Sami Labs, sister company of Sabinsa, has entered into a tripartite agreement with the Indian Institute of Integrative Medicine (IIIM) and the Indian Council of Medical Research (ICMR) that allowed Sami and Sabinsa to acquire two Indian patents pertaining to pterocarpus marsupium, an existing ingredient in the Sabinsa global product portfolio.

 The agreement was signed at IIIM by Ram A. Vishwakarma, Ph.D., director, IIIM; Sadhana Srivastava, Ph.D., scientist, ICMR; and Muhammed Majeed, Ph.D., founder and managing director, Sami Labs Limited. R. K. Raina, Ph.D., consultant to IIIM; Sarang Bani, Ph.D., director, biological science at Sami Labs; and Abdul Rahim, head of PME, were also present.

IIIM, based in Jammu, is one of the oldest institutions of the Council of Scientific and Industrial Research (CSIR), and was established in 1957. It is dedicated to advanced research on the isolation and standardization of drugs from natural products useful against various diseases. ICMR has led research on the isolation of novel compounds from pterocarpus marsupium for blood sugar management and two novel compunds were isolated, which showed significant activity in that area.

The two Indian patents for Sami/Sabinsa are: “A process for isolation of novel compound 2,6-dihydroxy-2-(P-hydroxybenzyl)-3(2H)-benzofuranone-7-C-ß-D-glucopyranoside from pterocarpus marsupium" under Patent No. 192163 “A process for extraction of antidiabetic formulation mainly containing flavonoid glycosides" under Patent No. 194292